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First Time in Man Trial for Friulimicin B

This study has been terminated.
(Unfavourable Pharmakokinetics)
Sponsor:
Information provided by:
MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00492271
First received: June 25, 2007
Last updated: July 22, 2008
Last verified: July 2008
History of Changes

June 25, 2007
July 22, 2008
June 2007
September 2007   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of single and multiple intravenous doses of Friulimicin B by assessing adverse events, physical examinations,clinical chemistry examination, hematology, ECG and urinalysis. [ Time Frame: 5 days ]
Same as current
Complete list of historical versions of study NCT00492271 on ClinicalTrials.gov Archive Site
  • To determine the pharmacokinetic profile of single and multiple intravenous doses of Friulimicin B in healthy subjects [ Time Frame: 5 days ]
  • To determine the bactericidal activity of serum obtained from healthy subjects after administration of Friulimicin B [ Time Frame: 5 days ]
Same as current
 
 
 
First Time in Man Trial for Friulimicin B
A Double-Blind, Placebo-Controlled, Randomized, Dose-Escalating Study of Single (Part A) and Multiple (Part B) Intravenous Doses of Friulimicin B in Healthy Subjects

The purpose of this study is to study the safety of single doses and multiple doses of Friulimicin B in healthy volunteers. The level of Friulimicin B will be measured in the subjects blood and urine. One part of the study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.

Continued widespread use of antibiotics has promoted the spread of antibiotic resistance and has created an urgent need for antibacterial agents with no known cross resistance to other antibiotics available for humans. Friulimicin B has been shown to be highly active against a range of bacteria including such important pathogens such as methicillin resistant Staphylococcus aureus (MRSA), drug resistant Streptococcus pneumoniae and Glycopeptide resistant Enterococcus spp. These organisms are the causative agents in serious infections such as skin and soft tissue infections, pneumonia, bacteremia and endocarditis, complicated urinary tract infections, and osteomyelitis.

This study is the first use of Friulimicin B in man and will examine its safety and a preliminary study will assess if Friulimicin B in the plasma of subjects has activity against bacteria.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Community Acquired Pneumonia
  • Staphylococcal Skin Infections
Drug: Friulimicin B
Intravenous, once daily, single dose
Experimental: 1
Experimental arm with increasing dosage
Intervention: Drug: Friulimicin B
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female healthy subjects
  • 18-55 years of age
  • In good health

Exclusion Criteria:

  • Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00492271
CNB-001
No
Michael Sieberling, MD; Principal Investigator, SWISS PHARMA CONTRACT LTD, Basel, Switzerland
MerLion Pharmaceuticals GmbH
 
Principal Investigator: Michael Sieberling, MD Swiss Pharma Contract
MerLion Pharmaceuticals GmbH
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP